Darolutamide

  • Part D specialty tier in 80% of formularies (2026Q3)
  • NUBEQA

Therapy management checklist

Screening, baseline and ongoing monitoring with the label's stated frequency, hold and discontinue criteria, and counseling points, each quoted from the FDA label.

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Storage and cold chain

Darolutamide: storage and handling

Freezing
Not addressed
Room temperature
at or below 30°C (86°F)
Label statement
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] .
Room temperature
at or below 25°C (77°F)
Label statement
Store NUBEQA at room temperature between 68°F to 77°F (20°C to 25°C).
Back into the refrigerator
Not addressed
Light
Not addressed
Shaking
Not addressed

Temperature excursion helper

Answers only from this label's storage statements. It does not judge whether a product is still usable beyond what the label states.

Within the label's stated room-temperature allowance (at up to 30°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] .

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-888-842-2937 (the number printed on the label) about this product.

Where the label prints this number
at Bayer at 1-888-842-2937 or go to www.NUBEQA-us.com 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Ischemic Heart Disease Inform patients that NUBEQA has been associated with an increased risk of ischemic heart disease.
All storage statements on the label (2)
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] .
  • Store NUBEQA at room temperature between 68°F to 77°F (20°C to 25°C).

FDA label version 23, effective June 3, 2025. DailyMed

Dosing and titration calendar

Built only from the schedules the label states (loading, titration, day schedules, cycles and weight bands). Steps the label states in words the calendar cannot place are shown, not guessed.

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Medicare Part D coverage

100%of plans list it
98%of those: prior authorization
0%step therapy
80%quantity limit
97%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

No manufacturer program page is listed for this drug yet.

Independent foundations and the full directory (checked 2026-11-06). Eligibility and amounts are set by each program; open its page for them.

For licensed clinicians. Use with clinical judgment. Statements are quoted from the FDA label; confirm against the label for the product you are using.